Improving Cognitive Function in Older Adults Undergoing Stem Cell Transplant (PROACTIVE)
Leukemia, Lymphoma, Multiple Myeloma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Hematopoietic cell transplantation
Eligibility Criteria
Arm 1:
Inclusion Criteria for Participants:
- age 60 years and older
- have a diagnosis of hematological malignancy
- have received autologous or allogeneic HCT within the prior 3-6 months
- able to speak and read English
- have provided written informed consent
Exclusion Criteria for Participants:
- there are no exclusion criteria
Inclusion Criteria for Participants' Care-Partner:
- age 19 years and older
- able to speak and read English
Exclusion Criteria for Participants' Care-Partner:
- there are no exclusion criteria
Inclusion Criteria for Transplant Team Member:
- age 19 years and older
- able to speak and read English
Exclusion Criteria for Transplant Team Member:
- there are no exclusion criteria
Arms 2 and 3:
Inclusion Criteria for Participants:
- age 60 years and older
- have a diagnosis of hematological malignancy
- planned to receive an autologous or allogeneic HCT
- able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
- (In Arm 3 only): willingness to be randomized to either the physical activity intervention or survivorship education active control condition, and to follow the protocol for the group to which they have been assigned
- able to speak and read English
- have provided written informed consent
Exclusion Criteria for Participants:
- development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
- is not cleared to participate in exercise by a physician
Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:
- Myocardial infarctions in the past 3 months
- Resting or unstable angina
- Uncontrolled and/or serious arrhythmias
- 3rd degree heart block
- Acute congestive heart failure or ejection fraction <30%
- Clinically significant aortic stenosis
Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:
o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
- other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition
Inclusion Criteria for Participants' Care-Partner:
- age 19 years and older
- able to speak and read English
- able to walk 4 meters as part of the Short Physical Performance Battery (with or without assistance)
- have no medical contraindications for participating in light to moderate-intensity physical activity per PI review of medical history as reported on the care-partner medical history form
Exclusion Criteria for Participants' Care-Partner:
- development of chest pain, severe shortness of breath, or occurrence of other safety concerns during the physical performance measures (i.e. Short Physical Performance Battery)
- is not cleared to participate in exercise by a physician
Individuals with the following current conditions/diagnoses documented in medical history will be required to provide clearance for exercise from their cardiologist:
- Myocardial infarctions in the past 3 months
- Resting or unstable angina
- Uncontrolled and/or serious arrhythmias
- 3rd degree heart block
- Acute congestive heart failure or ejection fraction <30%
- Clinically significant aortic stenosis
Individuals with the following conditions/diagnoses will be required to provide clearance for exercise from their surgeon:
o Hip fracture, hip or knee replacement, or spinal surgery in the past 3 months
- other medical, psychiatric, or behavioral factors that in the judgement of the principal investigator may interfere with study participation or the ability to follow either the intervention or the active control condition
Inclusion Criteria for Transplant Team Member:
- age 19 years and older
- able to speak and read English
Exclusion Criteria for Transplant Team Member:
- there are no exclusion criteria
Sites / Locations
- University of Nebraska Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Feedback for Preliminary Adaptation
Adapted CHAMPS-II intervention
Participants in Aim 1 will participate in qualitative interviews to obtain feedback on the CHAMPS-II intervention and survivorship education active control condition materials. Interviews will be with 1)adult participants 60+ years who have recently undergone HCT, 2)participants' care-partner, and 3)HCT team members.
All participants in Aim 2 (preliminary testing) and Aim 3 (RCT) will participate in the CHAMPS-II physical activity program adapted to the HCT setting. Testing for outcome measures will be completed, and feedback on the intervention will be obtained via qualitative interviews from 1)adult participants 60+ years receiving HCT, 2)participants' care-partner, and 3)HCT team members. Aim 3 participants will be randomized to either the immediate intervention (intervention then follow-up) or delayed intervention (wait period and then intervention).